Summary:
Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with general supervisor (GS) #1; the laboratory failed to verify the accuracy of ungraded compatibility testing for proficiency testing (PT) event 3 of 2018. Findings Include: 1. Review of American Proficiency Institute (API) PT results for the 3nd event of 2018 found 2 of 5 PT samples for compatibility were ungraded. Sample Performance SER-11 Not Graded SER-14 Not Graded 2. Review of the laboratory's policy, "Proficiency Testing", stated the following: "7. Upon receipt of evaluation results from API, the Lab Manager will review the outcome for each analyte, including assessment of non-graded tests, or scoring irregularities" 3. Review of the API document, "Proficiency Testing Performance Evaluation", found the laboratory designee reviewed and signed the document on 1-30-2019 and stated the following: